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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K942574
Device Name GRASPER, DISSECTOR, FORCEPS, NEEDLE HOLDER
Applicant
Acufex Microsurgical, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact LYNNE ARONSON
Correspondent
Acufex Microsurgical, Inc.
130 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact LYNNE ARONSON
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/31/1994
Decision Date 09/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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